The present invention relates to apparatuses for draining fluid from a patient, and more particularly, to fluid recovery systems for draining blood from the thoracic cavity of the patient.
A number of fluid-recovery systems have been developed for drawing fluid, such as blood, from a patient. Such devices generally apply suction to a body cavity of the patient to remove blood or other fluid after trauma or surgery. For example, a chest drain is a relatively compact bedside fluid-recovery system that is employed to collect fluids post-operatively from a closed surgical site through a drain tube implanted in the patient""s chest.
Conventional fluid-recovery systems typically include a housing and a number of components, such as valves and ports, that are manufactured separately from the housing, and subsequently attached to the housing. Such separate manufacturing of the components increases the number of steps in the manufacturing process, thereby increasing the manufacturing cost. Further, additional costs are incurred for assembling these components to the housing. Moreover, each separately manufactured component may need to be individually calibrated, further increasing the manufacturing cost of the system.
Accordingly, there is a need for a fluid-recovery system that requires fewer number of steps for its manufacturing, and further minimizes the need for calibration of its components.
The present invention provides a fluid-recovery system for collecting fluid from a patient which includes a housing having various integrally molded components and/or structures. The term integrally molded, as used herein, refers to forming a particular component and/or structure of the housing of the fluid-recovery system as a single unit with the remaining parts of the housing. In other words, an integrally molded component and/or structure is not added to a pre-formed housing, but rather is formed with other parts of the housing as a single unit. In particular, the integrally molded components and/or structures of the housing are not intended to be removed and/or replaced.
In one aspect, the present invention provides a fluid-recovery system having a housing and a valve for controlling fluid flow within the fluid-recovery system. The housing includes a collection chamber for collecting the fluid, and the valve includes a valve member that selectively engages a valve seat surrounding a fluid opening, to seal the opening. The valve seat is integrally molded to the housing of the fluid recovery system.
According to one aspect of the invention, the valve for controlling fluid flow within the fluid-recovery system is a vacuum protection valve that provides air flow communication with the collection chamber to permit air flow in one direction out of the collection chamber. In one preferred embodiment of the invention, the valve member of the vacuum protection valve is constructed of an elastomeric material and has a generally umbrella-like shape.
In another aspect, the present invention provides a fluid recovery system for collecting fluid from a patient that includes a housing having a collection chamber for collecting a volume of the fluid from the patient, and a vacuum protection valve for allowing air flow in one direction out of the collection chamber. The vacuum protection valve further includes an enclosure that is integrally molded within the housing.
In a preferred embodiment of the invention, the vacuum protection valve includes a flexible retaining member whose snap-action placement within the integrally molded enclosure secures the valve to the housing. The integrally molded enclosure can have a base extending to an opening that is sized and shaped to engage the flexible retaining member of the valve, thereby attaching the valve to the housing. The vacuum protection valve can include a valve body having an opening therein, and an umbrella valve member that is seated within the valve body to seal the opening. The umbrella valve member provides one way air flow through the opening when the pressure in the collection chamber exceeds a pre-defined threshold.
According to another aspect of the invention, the valve for controlling fluid flow within the fluid-recovery system is a negative pressure protection valve that opens to provide air flow between the collection chamber and the outside environment through the fluid opening when pressure in the collection chamber is lower than a predefined threshold.
In a preferred embodiment of the invention, the negative pressure protection valve can include a valve housing for seating a spring, and the valve member. The spring biases the valve member against the integrally molded valve seat to seal the fluid opening. A pressure in the collection chamber that is lower than the predefined threshold causes the spring to contract, thereby moving the valve member and providing air flow between the collection chamber and the outside environment. The negative pressure protection valve can optionally include a filter to filter the air before it enters the collection chamber. The valve housing can be integrally molded to the housing of the fluid recovery system. Alternatively, the valve housing can be a separate component that is seated within the integrally molded enclosure. The valve housing can include a first cylindrically tubular portion for receiving the spring and extending to a second portion for seating the valve member. The second portion of the valve housing can have at least one port therein for providing air flow between the valve housing and the collection chamber.
Accordingly to one aspect of the invention, an integrally molded raised structure protruding outwardly from the fluid opening of the negative pressure protection valve inhibits occlusion of the opening. The raised structure can include a hollow frusto-conical member that surrounds the fluid opening from the outside and has ports therein for providing air flow from the outside environment through the fluid opening.
According to yet another aspect of the present invention, a fluid-recovery system is provided that includes a collection chamber for collecting a volume of fluid from a patient, and a positive pressure relief valve for reducing pressure in the collection chamber when pressure in the chamber exceeds a pre-defined value. The pressure relief valve includes an integrally molded enclosure formed in the housing, and further includes an integrally molded ramped rib. The integrally molded enclosure of the pressure relief valve can include a first opening for providing air flow communication with the collection chamber, and a second opening for providing air flow communication with the outside environment. The first opening can have a tapered portion for seating a sealing ball that seals the first opening to provide a fluid-tight seal between the collection chamber and the integrally molded enclosure.
When pressure within the collection chamber exceeds a pre-defined value, it dislodges the ball from the first opening to allow air flow between the collection chamber and the outside environment. The integrally molded ramped rib provides a rolling surface for the sealing ball to bias the ball toward the first opening when the fluid recovery system is destabilized from a normal operating orientation. The term xe2x80x9cdestabilizedxe2x80x9d as used herein refers to situations or conditions in which the fluid recovery device is bumped, jarred, pushed, tipped or completely knocked-over, resulting in the device being positioned, temporarily or permanently, in an orientation other than its normal, preferred operating orientation, i.e., an orientation in which the fluid recovery system is upright. The pressure relief valve can include a raised surface surrounding the second opening to provide a seat for a sealing element that can seal the housing from the outside environment, for example when pressure testing the fluid-recovery system.
In another aspect, the fluid-recovery system of the invention can include a housing having a front face, a collection chamber integrally formed within the housing for collecting fluid, and a vacuum indicator for indicating when pressure in the collection chamber is below a selected threshold. The vacuum indicator includes a seat integrally molded in the front face of the housing, a translucent diaphragm, preferably formed of an elastomeric material, positioned in the seat, and a cap that is mounted to the seat to compress the diaphragm into sealing engagement with the seat. The cap has an opening therein that provides air flow between the collection chamber and the diaphragm, and further has a marking on a surface facing the diaphragm. When the pressure in the collection chamber is below the selected threshold, a pressure differential across the diaphragm develops that forces the diaphragm to contact the inside surface of the cap, thereby rendering the marking inside the cap discernable.
Alternatively, the front face can include a translucent portion, and the vacuum indicator can be a separate component that is positioned within the housing such that it is externally visible through the translucent portion of the front face.
In yet another aspect, the present invention provides a fluid-recovery system having a top surface, a collection chamber for collecting a volume of fluid from a patient, and a manually actuable pressure relief valve. The manually actuable relief valve includes an integrally molded enclosure within the top surface that is in air flow communication with the collection chamber. The integrally molded enclosure is sealed from the outside environment by a manually actuable diaphragm that is actuated by an integrally molded actuating element to provide air flow between the collection chamber and the outside environment to reduce pressure in the collection chamber.
Another aspect of the invention relates to providing a fluid-recovery system having a top surface, a collection chamber for collecting fluid from a patient, and a connecting element of a latching connector that is integrally molded to the top surface of the housing, and is configured to receive a mating connecting element of the latching connector. In one preferred embodiment of the invention, the connecting element is a female portion of a latching connector. In another preferred embodiment of the invention, the connecting element is a male portion of a latching connector.
In yet another aspect, the invention provides a fluid-recovery system having a housing that includes a collection chamber, and a pressure measuring port integrally molded within the housing. The integrally molded pressure port is configured to be in fluid communication with the collection chamber, and to receive a pressure gauge for measuring pressure within the collection chamber.
Another aspect of the fluid recovery system of the invention relates to a tamper-resistant disposal system for disposal of fluid collected within the collection chamber. The tamper-resistant system can preferably include a disposal port integrally molded to the housing, a seal positioned on the disposal port for sealing the disposal port, and a cap positioned over the seal and secured to the disposal port, to provide a air-tight seal of the disposal port. In a preferred embodiment of the invention, the cap includes a cap body, a cap base, and a plurality of break-away tabs along a circumference thereof, joining the cap body to the cap base. The cap further includes a plurality of ratchet-like teeth that can matingly engage with a plurality of ratchet-like teeth on the disposal port upon threaded engagement of the cap with the disposal port. The mating engagement of the two sets of teeth inhibits rotation of the base of the cap relative to the disposal port when the cap body is rotated relative to the disposal port. The cap can include a translucent portion to allow visual inspection of the seal.
Another aspect of the invention relates to providing a handle for the fluid-recovery system of the invention that is sized and shaped such that it allows safe and easy transport of the fluid-recovery system from one location to another. Such a handle is preferably formed as an integral part of the housing of the fluid recovery system, and is raised above other components on the top surface of the fluid recovery system. The length of the handle is selected such that it allows two people to simultaneously hold it. For example, in a preferred embodiment of the invention, the handle is approximately 5 inches long. Nevertheless, those skilled in the art will appreciate that handles having other lengths may be used to practice the present invention.
A preferred method for manufacturing various embodiments of the present invention includes forming a housing through an injection molding process, wherein the housing includes a collection chamber for collecting fluid and further includes other integrally molded components and/or structures for providing a number of different functions, such as relieving excess pressure in the collection chamber or indicating that the pressure in the collection chamber is below a selected threshold. For example, the injection molding process can be utilized to form an integrally molded enclosure within the housing for matingly engaging a vacuum protection valve.
These and other features and advantages of the present invention will be more fully understood by reference to the following detailed description in conjunction with the attached drawings in which like reference numerals refer to like elements through the different views.